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The effects of three small morning and evening doses of LSD on mood, biological and psychological measures of sleep, neuroplasticity, and well-being

The effects of three small morning and evening doses of LSD on mood, biological and psychological measures of sleep, neuroplasticity, and well-being

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27302
Enrollment
24
Registered
2021-11-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

LSD (20 µg) and to placebo

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Written Informed Consent • Understanding the procedures and the risks associated with the study. • At least 18 years of age • Absence of any major medical condition as determined by medical examination and laboratory analysis • Absence of any major psychological condition as determined by medical examination • Free from psychotropic medication • Participants must be willing to refrain from taking illicit psychoactive substances during the study. • Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day. • Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration. • Participants are asked to not make any substantial changes in their diet. • Participants must be willing to comply with guidelines regarding their bedtime. • Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2

Exclusion criteria

Exclusion criteria: • History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination) • Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks) • Pregnancy or lactation • Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg) • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) • Psychotic disorder in first-degree relatives • Any chronic or acute medical condition • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…) • For women: no use of a reliable contraceptive • Tobacco smoking (>20 per day) • Excessive drinking (>20 alcoholic consumptions per week) • Experience with a full dose of a psychedelic within the last three months

Design outcomes

Primary

MeasureTime frame
Primary objective is to investigate the effects of three repeated morning vs evening doses of LSD (20 µg) on mood.

Secondary

MeasureTime frame
Secondary objectives are to investigate the effects of three repeated morning vs evening doses of LSD (20 µg) on neuroplasticity, sleep parameters, cognitive performance measures, emotion regulation, markers of well-being, cortisol, and endocannabinoid levels.

Contacts

Public ContactEline Haijen

Maastricht University

e.haijen@maastrichtuniversity.nl+31433883517

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)